CLASS II Device recall · Reported 4 Sep 2019 · FDA Enforcement Report
Dosi-fuser 12591 5-500D1 -USA recalled by Leventon S. A. U
Leventon S. A. U is recalling Dosi-fuser 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a, distributed in Arizona, California, Florida, Massachusetts, Michigan, Puerto Rico. The recall was initiated on 23 May 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2360-2019
- FDA event ID
- 83017
- Recalling firm
- Leventon S. A. U, Barcelona, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 May 2019
- FDA classified
- 23 Aug 2019
- Reported
- 4 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Wheelchairs, Beds & Lifts
Timeline
| 23 May 2019 | Recall initiated by company | |
| 23 Aug 2019 | Classified by FDA | +92 days |
| 4 Sep 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
Product as listed by the FDA
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
Where it was distributed
US Distribution to states in: AZ, CA, MA, MI, PR, and FL.
Questions about this recall
Why was it recalled?
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
Which lots are affected?
172055L, 1721 10L, 1 807881, 181 1401 Unique Device Identifier (UDI) 08436020767470, 08436020768026
Where was it sold?
US Distribution to states in: AZ, CA, MA, MI, PR, and FL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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